Back to resultsEvaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
Primary Purpose
Crohn Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Certolizumab pegol
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease, Certolizumab pegol, Fistula
Eligibility Criteria
Inclusion Criteria: Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease Exclusion Criteria: Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome. All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient. Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Sites / Locations
Outcomes
Primary Outcome Measures
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
Secondary Outcome Measures
Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354367
Brief Title
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
Official Title
A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn Disease, Certolizumab pegol, Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Certolizumab pegol
Primary Outcome Measure Information:
Title
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
Secondary Outcome Measure Information:
Title
Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease
Exclusion Criteria:
Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient.
Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krassimir Mitchev, MD
Organizational Affiliation
UCB / Global Medical Affairs
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
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